New version: The 2019 ABPI/PMCPA Code of Practice for the Pharmaceutical Industry issued.​​​​​​​​​​​The Code sets standards for the promotion of medicines to health professionals and other relevant decision makers in the UK. It includes requirements for the provision of information to patients and the public and relationships with patient groups. The Code also applies to a number of areas that are non-promotional.The detailed provisions in the Code aim to ensure that pharmaceutical companies operate in a responsible, ethical and professional manner. ​​The Code covers:- journal, direct mail and digital advertising- the activities of representatives, including any materials used by themthe supply of samples- the provisions of inducements to prescribe, supply, administer, buy or sell medicines, by the gift, offer or promise of any benefit or bonus whether in money or in kind- the provision of hospitality- promotional meetings- the sponsorship of scientific and other meetings including payment of travel and accommodation expenses- all other sales promotion including exhibitions and digital communicationsthe provision of information to the public- relationships with patient organisations.Even if the 2019 version takes effect from 1st January 2019, PMCPA has issued a grace period until 30 April 2019 where no material or activity will be regarded as breaching the Code if failing to comply with any revised elements; however, the requirements of the current version (2016) must then be adhered to.Click here or on the picture for details.[Last updated 09 December 2018]

October is Breast Cancer Awareness MonthA worldwide annual campaign involving thousands of organisations, Breast Cancer Awareness Month highlights the importance of breast awareness, education and research.A number of activities are taking place at the Annual European Society for Medical Oncology in Munich, Germany – click here for details.Click here or on the picture to learn more about Breast Cancer Awareness Month.[Last updated 18 October 2018]

Eli Lilly’s CDK 4 and 6 inhibitor abemaciclib (Verzenios) has been approved in Europe for the treatment of certain metastatic breast cancers.The decision gives doctors the green light to prescribe the drug for women with hormone receptor-positive (HR+), epidermal growth factor receptor 2 negative (HER2–) locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor (AI) or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.The applications were based on the Phase III MONARCH 2 and 3 trials.In MONARCH 2, adding abemaciclib to AstraZeneca’s Faslodex (fulvestrant) significantly improved progression-free survival compared to Faslodex plus placebo, with figures of 16.4 months versus 9.3 months, respectively.MONARCH 3 evaluated abemaciclib in combination with an AI as initial endocrine-based therapy in postmenopausal women with HR+, HER2– advanced breast cancer who had no prior systemic treatment for advanced disease.The data show that combining the drug with an AI demonstrated a greater than 28-month median PFS in patients who received initial endocrine-based therapy for metastatic disease (28.2 months vs 14.8 months for placebo/AI).Click here or on the picture for details.​[Last updated 07 October 2018]

Nobel Prize 2018US researcher James Allison and Japanese researcher Tasuku Honjo have won the 2018 Nobel Prize for Physiology or Medicine for their ground-breaking work on manipulating the immune system to combat cancer.“By stimulating the inherent ability of our immune system to attack tumour cells this year’s Nobel Laureates have established an entirely new principle for cancer therapy,” said the Nobel Assembly at Sweden’s Karolinska Institute.Allison studied a known protein that functions as a brake on the immune system, and realised the potential of releasing the brake and thereby unleashing our immune cells to attack tumours. He then developed this concept into a brand-new approach for treating patients.Tasuku Honjo discovered a protein on immune cells and, after exploring its function, eventually revealed that it also operates as a brake, but with a different mechanism of action. Therapies based on his discovery proved to be strikingly effective in the fight against cancer.D2MM congratulates them both – and the entire scientific world – with these ground-breaking discoveries which have led to so many patient benefits.Click here or on the picture to see the The Noble Prize Committees announcement.[Last updated 07 October 2018]

FOUR PHARMA COMPANIES NAMED FOR BREACHING ABPI CODE OF PRACTICEMartindale Pharma, Pierre Fabre, Janssen and Pharmasure have all been named in advertisements for breaching the Association of the British Pharmaceutical Industry’s Code of Practice.According to the ABPI’s Prescription Medicines Code of Practice Authority (PMCPA), all have brought discredit upon and reduced confidence in the pharmaceutical industry.Pierre Fabre was reprimanded for briefing representatives about Toviaz (fesoterodine) “using an uncertified presentation and failing to provide complete information,” the PMCPA said, and thus breached four Code clauses, including: Clause 14.1, failing to certify promotional material; and Clause 15.9, producing representatives’ briefing material that did not comply with the relevant requirements of the Code.The firm was also found to have breached seven clauses of the Code by failing to certify representatives’ briefing materials and one presentation aimed at health professionals which promoted an unlicensed medicine, including briefing materials related to Toviaz that were misleading, and “not capable of substantiation”.For advertising Espranor oral lyophilisate (buprenorphine) to the public and for making claims in material aimed at patients and health professionals that were “prejudicial to patient safety”, Martindale was found to have breached eight clauses of the Code.These include Clause 9.1, failing to maintain high standards, Clause 7.2, providing misleading information, and Clause 26.1, advertising a prescription only medicine to the public.Janssen broke rules by promoting a medicine prior to it having received authorisation, breaking three clauses, while for providing a group of health professionals with a hamper of chocolates, Pharmasure also breached three requirements of the Code, including Clause 18.1, providing a gift in connection with the promotion of medicines.Click hereor on the picture for details.[Last updated 24 July 2018]